Application 205993

Type
ANDA
Sponsor
PADDOCK LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL8MEQNoNo
002POTASSIUM CHLORIDEPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL10MEQNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205993-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05
A205993-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A205993-001AB2
A205993-002AB2

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0584e616aacf4f…
2026-09-14 22:38:342026-08A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0584e616aacf4f…
2026-08-18 06:07:402026-07A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0574a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A205993-001AB2184e616aacf4f…
2026-09-14 22:38:342026-08A205993-002AB2184e616aacf4f…
2026-08-18 06:07:402026-07A205993-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A205993-002AB21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205993-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205993-002AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-002AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205993-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205993-002AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-002AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-002AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-002AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-002AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-002AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-002AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205993-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A205993-002AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-002AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-002AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-002AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205993-001AB218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205993-002AB218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-001AB215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-002AB215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205993-001AB215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205993-002AB215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205993-001AB214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205993-002AB214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205993-001AB2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205993-002AB2174a2ff9319b5…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC3dfa63fc-f8de-f1e0-e063-6294a90a8d472025-09-04Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC3dfac7ca-2c2e-e709-e063-6394a90adbb32025-09-04Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEKesin Pharma Corporation440dcbbb-bb31-d3fd-e063-6294a90ab2f72025-09-01Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions8f6ea056-5e10-4de1-97f0-55f0655a6f782025-08-27Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions8757d093-747b-4e97-af6d-4064b16178b22025-08-27Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAmerican Health Packaging149770d0-3a2c-4e75-80a3-ec842907920d2025-08-25Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEHenry Schein, Inc.bf8e8ac7-e6a8-4571-a0ea-7bcab89290f62025-08-12Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAvKARE3bdfced1-6e62-9e92-e063-6294a90a28aa2025-08-08Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC3be29fcc-765e-8653-e063-6394a90a59d52025-08-08Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
KLOR-CONPOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLC4340c3f2-ecf8-44cd-9b69-217f543e24e22025-08-08Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDESlate Run Pharmaceuticals, LLC94ae03cc-b620-0dbb-e053-2a95a90a922c2025-08-07Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDESlate Run Pharmaceuticals, LLC0cc57ece-f15a-4160-a5ea-8d6fa9f9e7542025-08-07Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.47a87fb6-5e61-41c9-b759-10f7c74a67ce2025-08-05Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAmerican Health Packaging7956883f-0d31-4081-bbea-d9ea320a193b2025-08-04Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC3b403d60-4246-d765-e063-6394a90a12e82025-07-31Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEA-S Medication Solutions162a8ab5-76cf-48fa-8487-7780ed65647e2025-07-31Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEA-S Medication Solutions14db14ba-fd0d-4b2a-9f1c-a62b3b82306f2025-07-31Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CHLORIDE
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAvKARE8baf3f25-c78b-6c08-e053-2995a90a667e2025-07-23Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAvKARE8bb030b7-104a-373b-e053-2995a90ab5802025-07-23Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEGuardian Drug Company296eda62-ea8e-7a0c-e063-6294a90a92742025-07-22Warnings, Adverse reactionsName fallback
brand name: Potassium Chloride
generic name: POTASSIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-0274Potassium chloride extended releasePotassium chloridePaddock Laboratories, LLCANDACurrent
0574-0274Potassium chloride extended releasePotassium chloridePadagis US LLCANDACurrent
0574-0274Potassium chloride extended releasePotassium chloridePadagis US LLCANDACurrent
0574-0275Potassium chloride extended releasePotassium chloridePaddock Laboratories, LLCANDACurrent
0574-0275Potassium chloride extended releasePotassium chloridePadagis US LLCANDACurrent
0574-0275Potassium chloride extended releasePotassium chloridePadagis US LLCANDACurrent
55154-6709Potassium chloride extended releasePotassium chlorideCardinal HealthANDACurrent
55154-6709Potassium chloride extended releasePotassium chlorideCardinal HealthANDACurrent
55154-6709Potassium chloride extended releasePotassium chlorideCardinal Health 107, LLCANDACurrent
55154-6709Potassium chloride extended releasePotassium chlorideCardinal HealthANDACurrent
63629-8442Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8442Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8442Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8443Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8443Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8443Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8700Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8700Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
63629-8700Potassium chloride extended releasePotassium chlorideBryant Ranch PrepackANDACurrent
70518-2291Potassium chloride extended releasePotassium chlorideREMEDYREPACK INC.ANDACurrent
71205-996Potassium chloride extended releasePotassium chlorideProficient Rx LPANDACurrent
71205-996Potassium chloride extended releasePotassium chlorideProficient Rx LPANDACurrent